Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Batch/Lot Information

Details about batches of the drug product and substance, with identifiers.

Product

Resources

Medicinal Product Definition	The drug product (Stelbat tablets, 20mg)
Medication	Identifying information about the actual batches of the product (instances)

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.P.5 Control of Drug Product
  • 3.2.P.5.4 Batch Analyses

XML and JSON examples of synthetic CTD data:

• Product Batch or Lot information example XML
• Product Batch or Lot information example JSON

HTML rendering of synthetic CTD data:

• Drug Product Batch or Lot Information

Substance

Resources

SubstanceDefinition	The substance itself
Substance	Identifying information about the actual batches of the substance (instances)

Examples

eCTD section synthetic source data samples (PDF):

• 3.2.S.4 Control of Drug Substance
  • 3.2.S.4.4 Batch Analyses

XML and JSON examples of synthetic CTD data:

• Substance Batch or Lot information example XML
• Substance Batch or Lot information example JSON

HTML rendering of synthetic CTD data:

• Drug Substance Batch or Lot Information

  Profiles

  See Artifacts Index: Batch or Lot Information